Manager:in für Produktzulassungen (m/w/d)
Core
Manage regulatory strategies and documentation for global medical device approvals, ensuring compliance with national and international regulations.
Role type
Manager, Medical Device Regulatory Affairs
Builds
Regulatory strategies and technical documentation for global market entry
Domain
Medical devices / Dental materials
Required skills
Technical documentation management, Clinical evaluation, Regulatory compliance monitoring, Cross-functional communication, Data sheet administration, Chemical regulation tracking
Preferred skills
University degree, Technical interest, English fluency, Organizational skills, Assertiveness
Technologies
Medical device regulatory frameworks, Technical documentation systems
Responsibilities
Administer technical and safety data sheets for medical and non-medical products, Create and maintain technical documentation, Conduct clinical evaluations to support registration, Act as interface between Quality/Regulatory and R&D departments, Monitor chemical regulatory requirements